The purpose of this position is to assist Quality Systems Management in maintaining a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Principal Quality Engineer – Risk Management functions as a subject-matter resource for Risk Management.

Essential Job Functions

Represents the Corporation, Division and Quality Department in a professional manner.

Program leader ensuring new methods and processes and review technical instructions to ensure compliance with Department and Division procedures and regulatory standards, with an emphasis in Risk Management.

Oversees Risk Management documents developed to support development projects. Ensures that principals of Design Control & Risk Management are applied to Product and Process Changes and all design phases for New Product Development and/or product enhancements.

Interfaces with manufacturing facility or other Division Facilities, as required.

Serves as Independent QA Reviewer for Design Reviews and participate in Phase Reviews, as required.

Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner, desired.

Basic Qualifications

Comprehensive knowledge of quality systems and relationship to business.

Extensive knowledge of medical device regulation, industry or international standard, including risk management. Ability to perform engineering work of a broad nature with little or no direction.

Strong expertise in engineering concepts and statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. Perform Data/Statistical analysis, as needed.

Well-versed in statistics, data presentation, and analysis application to business problems.

Ability to serve in leadership roles on projects or assignments.

Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.

Broad knowledge of manufacturing processes.

Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.

BD Urology and Critical Care is currently hiring a Quality Engineers, Risk Management, Post Market Programs, & Quality Engineer I(s). These positions are a growth opportunity based in Covington, GA. Formerly Bard Medical, we have joined Becton-Dickinson a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.